Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:43 AM
Ignite Modification Date:
2025-12-25 @ 2:43 AM
NCT ID:
NCT00086333
Eligibility Criteria:
Inclusion Criteria:
* Patients with pathologically confirmed stage IIIB or IV NSCLC with a minimum of 1 measurable baseline target lesion who have received no prior chemotherapy for metastatic disease and are not eligible for combined modality therapy with curative intent
* Patients must have an ECOG performance status of less than or equal to 2
* -Patients must have a tumor block available for documentation of LeY antigen expression by immunohistochemistry
* -FDG-PET imaging must be completed at a PET center approved by Seattle Genetics
* Patients must have adequate bone marrow and hepatic function
Exclusion Criteria:
* -Prior cytotoxic therapy for metastatic NSCLC
* -Those with serious underlying non-malignant disease
* -Patients with peripheral neuropathy \> Grade 2 are excluded from study
* -Patients with IDDM or NIDDM
* Patients with known active viral, bacterial, or symptomatic fungal infection
* Concomitant with other antineoplastic or experimental agents
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00086333
Study Brief:
Protocol Section:
NCT00086333